Infusion pump incorporating information from personal information manager devices

ABSTRACT

This document discusses, among other things, an apparatus comprising a pump configured to deliver a fluid, a wireless communication port and a controller. The controller is configured to communicate with a separate device via the communication port to receive information relating to a calendar event stored on an interactive calendar of the separate device. The controller can alter operation of the apparatus based on the calendar event.

RELATED APPLICATION

This application is a continuation of application Ser. No. 13/482,106filed May 29, 2012, which in turn is a continuation of application Ser.No. 12/914,295 filed Oct. 28, 2010, now U.S. Pat. No. 8,414,523 issuedApr. 9, 2013, which in turn is a division of application Ser. No.11/971,351 filed Jan. 9, 2008, now abandoned, each of which is herebyfully incorporated herein by reference.

BACKGROUND

People who suffer from diabetes require insulin to keep their bloodglucose level as close as possible to normal levels. It is essential forpeople with diabetes to manage their blood glucose level to within anormal range. Complications from diabetes can include heart disease(cardiovascular disease), blindness (retinopathy), nerve damage(neuropathy), and kidney damage (nephropathy). Insulin is a hormone thatreduces the level of blood glucose in the body. Normally, insulin isproduced by beta cells in the pancreas. In non-diabetic people, the betacells release insulin to satisfy two types of insulin needs. The firsttype is a low-level of background insulin that is released throughoutthe day. The second type is a quick release of a higher-level of insulinin response to eating. Insulin therapy replaces or supplements insulinproduced by the pancreas.

Conventional insulin therapy typically involves one or two injections aday. The low number of injections has the disadvantage of allowinglarger variations in a person's insulin levels. Some people withdiabetes manage their blood glucose level with multiple daily injections(MDI). MDI may involve more than three injections a day and four or moreblood glucose tests a day. MDI offers better control than conventionaltherapy. However, insulin injections are inconvenient and require adiabetic person to track the insulin doses, the amount of carbohydrateseaten, and their blood glucose levels among other information criticalto control.

It is important for a diabetic person to be treated with the properamount of insulin. As discussed previously, high blood sugar can lead toserious complications. Conversely, a person with low blood sugar candevelop hypoglycemia. Ideally, insulin therapy mimics the way the bodyworks. An insulin pump is one way to mimic the body's insulinproduction. An insulin pump can provide a background or basal infusionof insulin throughout the day and provide a quick release or bolus ofinsulin when carbohydrates are eaten. If a person develops high bloodsugar, a correction bolus can be delivered by the pump to correct it.While insulin pumps improve convenience and flexibility for a diabeticperson, they can be sophisticated devices. It is desirable for aninsulin pump to have features that make the pump more convenient or moreeffective for the patient to use.

SUMMARY

This document discusses, among other things, devices and methods formanaging infusion therapy. A device example includes a pump configuredto deliver a fluid, a wireless communication port, a controller, and ahousing to enclose the apparatus. The controller is configured tocommunicate with a second device via the communication port using anopen standard wireless communication protocol. The housing includes amechanical coupling to slidably engage the second device which includesa second wireless communication port. Slidably engaging the seconddevice positions the first and second communication ports opposite eachother to allow communication via the first and second communicationports when slidably engaged.

A method example includes positioning a mechanical coupling on a housingthat encloses the pump device so that the mechanical coupling slidablyengages a second device, positioning a first wireless communication portin relation to the mechanical coupling such that, when the second deviceis in a slidably engaged position, the first wireless communication portis positioned opposite a second wireless communication port of thesecond device, and communicating with the second device via the firstand second communication ports using an open standard wirelesscommunication protocol.

This section is intended to provide an overview of the subject matter ofthe present patent application. It is not intended to provide anexclusive or exhaustive explanation of the invention. The detaileddescription is included to provide further information about the subjectmatter of the present patent application.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsmay describe similar components in different views. Like numerals havingdifferent letter suffixes may represent different instances of similarcomponents. The drawings illustrate generally, by way of example, butnot by way of limitation, various embodiments discussed in the presentdocument.

FIGS. 1A and 1B illustrate portions of a device that includes an insulinpump.

FIG. 2 is a block diagram of portions of a system to provide add-onfeatures to an insulin pump device.

FIG. 3 is an illustration showing a mechanical coupling for an add-onmodule.

FIG. 4 shows a flow diagram of an embodiment of a method to provideadd-on features to an insulin pump device.

FIG. 5 shows a flow diagram of an embodiment of method to manage bloodglucose of an insulin pump user in response to activity.

FIG. 6 is a block diagram of portions of an embodiment of a device thathelps a user manage their blood glucose in response to activity.

FIG. 7 is a block diagram of portions of another embodiment of a devicethat helps a user manage their blood glucose in response to activity.

FIG. 8 shows an example of a table that indexes an amount ofcarbohydrates to an intensity and duration of exercise.

FIG. 9 is a block diagram of portions of still another embodiment of adevice that helps a user manage their blood glucose in response toactivity.

FIG. 10 is a flow diagram of an embodiment of a method of assisting aninsulin pump user in managing their diabetes.

FIG. 11 is a block diagram of portions of an embodiment of a system thatincludes compressed audio files to assist an insulin pump user inmanaging their diabetes.

FIG. 12 is a flow diagram of an embodiment of a method to monitorinsulin temperature.

FIG. 13 is a block diagram of portions of a device to monitortemperature of insulin.

FIG. 14 is a flow diagram of an embodiment of a method of determining anamount of insulin to deliver in a bolus in response to a pump useringesting a meal.

FIG. 15 is a block diagram of an embodiment of a device to determine anamount of insulin in an insulin bolus using food nutrient information.

FIG. 16 illustrates a graph of an example of a combination bolus ofinsulin.

FIG. 17 is a flow diagram of another embodiment of a method ofautomatically determining an amount of insulin to deliver in a bolus.

FIG. 18 is a block diagram of another embodiment of a device toautomatically determine an amount of insulin in an insulin bolus usingfood nutrient information.

FIG. 19 shows a flow diagram of an embodiment of a method to program aninsulin pump device using an interactive calendar.

FIG. 20 is a block diagram of portions of an embodiment of a system thatincludes an insulin pump device.

FIG. 21 is a flow diagram of an embodiment of a method of operating aninsulin pump device.

FIG. 22 is a block diagram of portions of an embodiment of a device toprovide voice control of insulin therapy.

FIG. 23 is block diagram of portions of an embodiment of a device toprovide insulin therapy.

FIG. 24 is a flow diagram of an embodiment of a method of extending thebattery life of an insulin pump.

DETAILED DESCRIPTION

Insulin pumps can be sophisticated devices. Additional pump features mayassist an insulin pump user in being more effective in treating theirdiabetes. FIGS. 1A and 1B illustrate portions of a device 100 thatincludes an insulin pump. The device 100 includes a cassette orcartridge of insulin. The cartridge is connectable to infusion tubing140 connectable to a patient such as by a Luer lock 145 or infusion set142. The device 100 includes a display 102 and a user interface that mayinclude the display 102 and include one or more keys 104 in a keypad.Because it is important for an insulin pump user to properly treat theirdiabetes using the pump, it is desirable for a pump to have featuresthat make the pump more convenient or more effective to use. Thefeatures may be integral to the device or may be provided by add-onmodules.

Add-on Module

FIG. 2 is a block diagram of portions of a system 200 to provide add-onfeatures to an insulin pump device to expand its functional capability.The system 200 includes a first device 205 and a second device 210. Thefirst device 205 includes a pump 215 configured to deliver insulin, afirst wireless communication port 220, and a controller 225.

The pump 215 may be a positive displacement pump. Descriptions of anexample of a medication pump to deliver insulin are found in Vilks etal., “Cartridge and Rod for Axially Loading a Medication Pump,” U.S.Pat. No. 7,033,338, filed Feb. 28, 2002, which is incorporated herein byreference in its entirety. The pump 215 may drive a plunger in aremovable insulin cartridge to deliver the insulin. The first wirelesscommunication port 220 may be an infrared (IR) communication port, orthe first wireless communication port 220 may be a radio communicationport (e.g., a radio frequency or RF port).

The controller 225 can be implemented using hardware circuits, firmware,software or any combination of hardware, firmware, and software.Examples, include a microcontroller, a logical state machine, a fieldprogrammable gate array (FPGA), application specific integrated circuit(ASIC), and a processor such as a microprocessor, digital signalprocessor, or other type of processor. The controller 225 is configuredto perform or execute a function or functions. Such functions correspondto modules to provide features integral to the first device. Modules maybe software, hardware, firmware or any combination thereof. Multiplefunctions may be performed in one or more modules. In some embodiments,software or firmware is provided on a computer readable medium. Thecomputer readable medium includes instructions therein, which whenprocessed (such as by the controller 225 for example) results in adevice performing the functions described herein. Examples of a computerreadable medium include a compact disc (CD), memory stick, or remotestorage accessible via a communication network such as the internet or acell phone network.

The second device 210 includes a second wireless communication port 230.The second device 210 provides a feature or features to the first device205 by communicating information via the wireless ports. In this way thesecond device 210 is an add-on module to the first device. Add-onmodules perform a function or functions external to the first device205. The functions may be performed by a controller included in thesecond device 210.

FIG. 3 is an illustration showing a mechanical coupling of the firstdevice 305 and the second device 310. The first device 305 includes ahousing 335 that encloses the first device 305. The housing 335 includesa mechanical coupling 350 to slidably engage the second device 310. Byslidably mounting the second device 310 next to the insulin cartridgecap 340 of the first device 305, the first device 305 does not have tobecome any thicker and the change in effective length can be minimizedby using the empty space next to the insulin cartridge cap 340. Thisprevents a module added-on to the insulin pump device from making thedevice more cumbersome for the user to wear. The slide mounting alsoallows for quick and easy attachment by the user; making it more likelythat the user will use the add-on module.

In some embodiments, the mechanical coupling 350 includes a lockingmechanism to lock the second apparatus in the slidably engaged positionand the second device 310 includes a release mechanism to release thesecond device 310 from the slidably engaged position, or to otherwisedetach the second device 310 from the first device 305. In certainembodiments, the release mechanism is a release button that may belocated on a side surface 355 of the second device. In some embodiments,the second device 310 includes a battery tray that slides into thebottom surface 345 of the second device.

In some embodiments, slidably engaging the second device 310 and thefirst device 305 positions the first wireless communication port 220 ofFIG. 2 opposite the second wireless communication port 230. This allowsinfrared communication ports to be aligned for communication. In someembodiments, the first device 205 and the second device 210 communicateusing a proprietary protocol. In some embodiments, the first device 205and the second device 210 communicate using an open standard wirelesscommunication protocol. An example of an open standard wirelesscommunication protocol includes, among other things, the Infrared DataAssociation (IrDA) protocol. Use of an open standard wirelesscommunication protocol may ease development of add-on modules for theinsulin pump device.

In some embodiments, the second device 210 includes a blood glucosemonitor. A blood glucose monitor or meter measures blood glucose levelsusing a sample of blood or of interstitial fluid. Some monitors requirea finger-stick to acquire the sample that is applied to a test strip toget a blood glucose reading. Some monitors are able to providecontinuous monitoring of blood glucose. A continuous blood glucosemonitor may include a blood glucose sensor circuit to produce anelectrical blood glucose signal representative of a blood glucose levelof the patient. A description of a blood glucose sensor circuit can befound in Steil et al., “Closed Loop System for Controlling InsulinInfusion,” U.S. Pat. No. 6,558,351, filed Jun. 1, 2000, which isincorporated herein by reference in its entirety. The blood glucosemonitor provides information regarding the blood glucose level of theuser (e.g., blood glucose data) to the first device 205.

In some embodiments, the second device 210 includes a glycosylatedhemoglobin (Hb_(A1c)) tester. When a diabetic is not effectivelycontrolling their diabetes, blood sugar combines with hemoglobin and thehemoglobin becomes abnormally glycated. The Hb_(A1c) tester determinesif the Hb_(A1c) level of the user is within a normal range. In someembodiments, the second device 210 includes an activity monitor. Theactivity monitor includes a sensor that produces an activity sensorsignal that is representative of the activity of the user. In someembodiments, the activity sensor is an accelerometer. In someembodiments, the activity monitor includes a pedometer function. Theactivity monitor provides information related to activity of a user. Insome embodiments, the second device 210 includes a blood ketone tester.Monitoring blood ketone level is useful to detect diabetic ketoacidosis.The blood ketone tester provides information regarding the blood ketonelevel of the user to the first device. Other embodiments of the seconddevice 210 implement any of the features described herein.

FIG. 4 shows a flow diagram of an example of a method 400 to provideadd-on features to an insulin pump device. At block 405, a mechanicalcoupling is positioned on a housing that encloses an insulin pumpdevice. The mechanical coupling slidably engages a second device.

At block 410, a first wireless communication port is positioned inrelation to the mechanical coupling such that when a second device is ina slidably engaged position, the first wireless communication port ispositioned opposite a second wireless communication port of the seconddevice. At block 415, the insulin pump device communicates with thesecond device via the first and second communication ports using an openstandard wireless communication protocol.

Activity Monitoring

Activity of the insulin pump user may lead to a change in insulintherapy of the user. A pump user may not always know when activity suchas exercise leads to a change in therapy, or the user may neglect toaddress a change required by the activity.

FIG. 5 shows a flow diagram of an embodiment of method 500 to manageblood glucose of an insulin pump user in response to activity. At block505, information related to activity of a user is received into a devicethat includes an insulin pump. At block 510, a change in insulin therapyis determined according to the activity information. At block 515, thechanged insulin therapy is delivered using the insulin pump device.

FIG. 6 is a block diagram of portions of an embodiment of a device 600that helps a user manage their blood glucose in response to activity.The device 600 includes a pump 615 configured to deliver insulin, aninput 622, and a controller 625. The controller 625 receives informationrelated to activity of a user of the apparatus via the input 622. Insome embodiments, the device 600 includes a user interfacecommunicatively coupled to the input 622. The communicative couplingallows the controller 6255 to exchange electrical signals with the input622 and pump 615 even though intervening circuitry may be present. Theuser interface may include one or more keys in a keypad. The controller625 receives the information related to activity of a user via the userinterface.

In some embodiments, the device includes a communication port 620 andthe controller 625 receives the information from a separate seconddevice. In certain embodiments, the communication port 620 is a wiredport (e.g., a universal serial bus (USB) port, Firewire port, or RS232port). In certain embodiments, the communication port 620 is a wirelessport (e.g., an IR port or an RF port).

In some embodiments, the second device that provides activityinformation is an add-on module that includes an activity monitor. Incertain embodiments, the activity monitor attaches to the device 600slidably as in FIG. 3. In certain embodiments, the activity monitorattaches to the device 600 by a clasp mechanism. Descriptions of devicesand methods that attach add-on modules to an insulin pump device arefound in Goodnow et al., “Glucose Measuring Module and Insulin PumpCombination,” U.S. Patent Publication No. 20040254434, filed Jun. 10,2003, which is incorporated herein by reference in its entirety.

The controller 625 includes an insulin calculation module 630. Theinsulin calculation module 630 calculates a change in insulin therapyaccording to the activity information. The controller 625 then initiatesdelivery of the changed insulin therapy. The change to insulin therapymay include a change to a meal bolus or carbohydrate bolus, a change toa correction bolus, a change to a basal infusion of insulin (e.g., abasal insulin rate pattern or basal rate profile), or may include theinsulin calculation module recommending that the user consumecarbohydrates.

FIG. 7 is a block diagram of portions of another embodiment of a device700 that helps a user manage their blood glucose in response toactivity. The device 700 includes a pump 715 configured to deliverinsulin, an input 722, a controller 725, and an insulin calculationmodule 730 included in the controller 725. The device 700 also includesa user interface 735. Information related to exercise of the user isreceived by the controller 725 via the user interface 735.

The insulin calculation module 730 uses the exercise information tocalculate an amount of carbohydrates metabolized by the exercise. Insome embodiments, the insulin calculation module 730 estimates theamount of carbohydrates metabolized by the exercise according to aconversion rule. For example, the insulin calculation module 730 mayestimate that the user metabolizes 15 to 30 grams every 30 to 60minutes. The exact conversion rule can be tailored for the pump user andprogrammed into the controller 725 by the user or a diabetesprofessional. The conversion rule can be programmed via the userinterface 735 or via a communication port 620 as shown in FIG. 6.

In some embodiments, the device 700 includes a memory 740. Theconversion rule is a lookup table stored in the memory 740. The lookuptable indexes the amount of carbohydrates metabolized according to theexercise intensity and the exercise duration. An exercise with a higherintensity (e.g., running) would have a higher intensity level andmetabolize more carbohydrates than an exercise with a lower intensity(e.g., golfing). An example of a table that indexes an amount ofcarbohydrates to the intensity and duration of exercise is the ExCarbsTable published by Diabetes Services, Inc. and reproduced in FIG. 8. Theintensity and duration of the exercise is entered via the user interface735. In some examples, the table includes the amount of carbohydratesmetabolized per amount of body weight (e.g., per 100 pounds). Theinsulin calculation module 730 calculates the amount of carbohydratesmetabolized by the exercise from the user's body weight.

The insulin calculation module 730 calculates a reduction of an amountof insulin in a bolus by an amount that covers the metabolized amount ofcarbohydrates. In some examples, the insulin calculation module 730calculates the reduction in insulin using a carbohydrate ratio stored inthe device 700. A carbohydrate ratio refers to the amount ofcarbohydrates covered by a unit of insulin. It is sometimes referred toas a carbohydrate factor, or carb factor, and is typically specified asgrams of carbohydrates per unit of insulin. The insulin calculationmodule 730 converts the amount of metabolized carbohydrates into anamount of insulin using the carbohydrate ratio and reduces the amount ofinsulin in a bolus by that amount. For example, the patient maymetabolize seventy grams of carbohydrates during an exercise session. Ifthe carbohydrate ratio is ten grams of carbohydrates per unit ofinsulin, the insulin pump may determine that seven units of insulin arerequired to cover the carbohydrates and reduce an amount of insulin in abolus by seven units.

In some embodiments, the insulin calculation module 730 reduces theinsulin in a meal bolus by an amount that covers the metabolized amountof carbohydrates. A meal bolus is an amount of insulin delivered inanticipation of, or in response to, eating a meal. In some examples, theinsulin calculation module 730 reduces the insulin in a correctionbolus. A correction bolus is a bolus of insulin designed to bring highblood glucose back to normal. In some examples, the insulin calculationmodule 730 reduces the insulin in a basal insulin rate pattern by anamount that covers the metabolized amount of carbohydrates. The insulincalculation module 730 temporarily reduces the rate of basal insulindelivery until the insulin reduction is covered and then restores theoriginal rate of basal insulin delivery.

In some embodiments, the device 700 includes a display 745. Aftercalculating an amount of carbohydrates metabolized by the exercise, theinsulin calculation module 730 recommend, via the display, that the userconsume the calculated amount of carbohydrates.

In some embodiments, one or more exercise regimens are stored in thememory 740. This is useful if the insulin pump user regularly repeats atype of exercise (e.g., regularly plays a round of golf at the same golfcourse or regularly runs a certain distance). An exercise regimen can belabeled “run” and can index a specified intensity and duration. Theexercise intensity and duration may be used to determine the amount ofmetabolized carbohydrates, such as by using a lookup table as describedpreviously. The exercise regimens may be received into the device 700via the user interface 735, or may be received into the device 700 froma second separate device via a communication port.

The device 700 receives an indication, via the user interface 735, thatthe user will exercise according to a stored exercise regimen. Inresponse to the received indication, the controller 725 presents on thedisplay 745 an exercise insulin delivery pattern corresponding to theexercise regimen. In some examples, the exercise insulin deliverypattern is a basal insulin rate pattern that includes a reduction ininsulin according to the carbohydrates metabolized during the exercise.The device receives, via the user interface, at least one of a selectionof the exercise insulin delivery pattern into the device or amodification to the exercise insulin delivery pattern into the device.The controller 725 then initiates delivery of the selected or modifiedexercise insulin delivery pattern. The user may also cancel the exerciseinsulin delivery pattern via the user interface 735.

FIG. 9 is a block diagram of portions of still another embodiment of adevice 900 that helps a user manage their blood glucose in response toactivity. The device 900 includes a pump 915 configured to deliverinsulin, an input 922, a controller 925, and an insulin calculationmodule 930 included in the controller 925. The device 900 includes anactivity sensor 950 communicatively coupled to the input 922. Theactivity sensor 950 provides activity information in the form of anactivity sensor signal that is an electrical signal representative ofpatient activity.

According to some embodiments, the device 900 includes a second input952 and a display 945. The controller 925 receives information relatedto blood glucose into the insulin pump device via the second input anddisplays activity information in association with the blood glucoseinformation on the device display 945. In certain embodiments, thecontroller 925 displays an indication of a period of high blood glucoselevel or a period of low blood glucose level on the device display 945together with activity information. In certain embodiments, thecontroller 925 displays indications of both periods of high and lowblood glucose levels together with an indication of activity level onthe device display 945.

In some embodiments, the device 900 includes a user interfacecommunicatively coupled to the second input 952. The controller 925receives information related to blood glucose entered manually via theuser interface.

In some embodiments, the device 900 includes a communication portcommunicatively coupled to the second input 952. The port may be a wiredport or a wireless port. The controller 925 receives information relatedto blood glucose via the communication port from a second separatedevice. In some examples, the second device is a blood glucose monitor.In some embodiments, the second device is a blood glucose monitorincluded in an add-module to the device 900. In some embodiments, ablood glucose monitor 955 is integral to the device 900 and iscommunicatively coupled to the second input 952.

According to some embodiments, the device 900 includes a memory 940 anda display 945. The memory 940 stores a basal insulin rate pattern for anindicated activity level. For example, the memory 940 may store onebasal rate pattern for an activity with an intensity level of “3” and adifferent basal rate pattern for an activity with an intensity level of“5”. The controller 925 includes an activity module 960. The activitymodule 960 uses the activity sensor signal from the activity sensor 950to determine an actual activity level of the patient during delivery ofthe basal insulin rate pattern, which may be different from theindicated activity level. The controller 925 displays an indication whenthe actual activity level deviates from the indicated activity level anddisplays a recommended change to the basal rate pattern.

In certain embodiments, if the actual level of exercise is less than theindicated level, the exercise basal rate pattern may not deliver enoughinsulin. The insulin calculation module 930 determines the differencebetween the actual carbohydrates metabolized and the amount ofcarbohydrates metabolized according to the stored indicated activitylevel and recommends an amount of insulin in a correction bolus to coverthe difference. In certain embodiments, if the actual level of exerciseis more than the indicated level, the exercise basal rate pattern maydeliver too much insulin. The insulin calculation module determines thedifference between the amount of carbohydrates covered by the insulinand the amount of carbohydrates metabolized, and the controller 925displays an indication for the user to eat an amount of carbohydratescorresponding to the calculated difference.

In some embodiments, the activity module 960 establishes a baselinelevel of patient activity for a period of time. The period of time maybe a period during the day when the pump user is more active, or may bea period of normal activity. In some examples, the activity module 960establishes a baseline level for a specific activity (e.g., playingtennis).

In certain embodiments, the activity module 960 establishes a baselineactivity level using a central tendency (e.g., an average value, or amedian value) of the activity sensor signal. The activity module 960then determines an actual level of patient activity during a time period(e.g., the time of day, or when the user indicates to the device 900that they are playing tennis) using the activity sensor signal, andcompares the actual level of patient activity to the baseline level. Ifthe actual level of patient activity exceeds the baseline level by athreshold value, the insulin calculation module calculates and displaysan amount of carbohydrates for the patient to consume.

If the actual level of patient activity is less than the baseline levelby the same or a different threshold value, the controller 925 promptsthe user, via the display 945, to initiate blood glucose tests morefrequently. In certain embodiments, if the activity module 960determines that the actual level of patient exercise is less than thebaseline level by more than a threshold value, the insulin calculationmodule 930 calculates an amount of insulin to deliver in a correctionbolus to bring the patient's blood glucose to a target level. Thecontroller 925 may then display the recommended amount to the pump userwho may then initiate the correction bolus through a user interface.

According to some embodiments, the memory 940 stores basal rate patternsin association with patient activity levels. For example, the memory 940may store exercise basal rate patterns to be used during or afterexercise. The activity module 960 determines a level of patient activityusing the activity sensor signal. The controller 925 activates theexercise basal rate pattern according to the level of patient activitydetermined by the activity module 960. As an illustrative example, thememory 940 may store one basal rate pattern for normal activity, a firstexercise basal rate pattern for an activity with an intensity level of“3”, and a second exercise basal rate pattern for an activity with anintensity level of “5”. When the activity module 960 determines that theactivity level of the patient is “3”, the controller 925 activates thefirst exercise basal rate pattern.

Other motion signatures in the activity sensor signal may provide otherinformation to the device 900. For example, a sudden spike in theactivity sensor signal may indicate that the device 900 underwent animpact. In some embodiments, the activity module 960 determines that theactivity signal exceeds a signal threshold value associated with theinsulin pump device undergoing an impact. In response to the determinedimpact, the controller displays a recommendation to check the insulinpump device, an insulin cartridge, or both the insulin pump device andinsulin cartridge for damage.

Audio Capability

Because visual indications may be too difficult for a sight impairedpump user to see on a display, audible indications from an insulin pumpmay be desirable. Also, audio indications may be useful in attracting anon-sight impaired pump user's attention to the device in case of apump-related alarm condition.

FIG. 10 is a flow diagram of a method 1000 of assisting an insulin pumpuser in managing their diabetes. At block 1005, information iscommunicated between a first device that includes an insulin pump and asecond device that includes a memory to store a plurality of compressedaudio data files. This includes at block 1010, communicating a commandfrom the first device to the second device to cause the second device toplay a compressed audio data file when the command is received. Theaudio data file may include an alert concerning the insulin pump device,or may include a status of the insulin pump device.

FIG. 11 is a block diagram of portions of an embodiment of a system 1100that includes compressed audio files to assist an insulin pump user inmanaging their diabetes. The system 1100 includes a first device 1105and a second device 1110. The first device includes a pump 1115configured to deliver insulin, a communication port 1120, and acontroller 1125 communicatively coupled to the pump 1115 and thecommunication port 1120. The controller 1125 communicates with thesecond device 1110 via the communication port 1120. The communicationport 1120 may be a wired port or a wireless communication port.

The second device 1110 includes a processor 1127 and a memory 1140integral to or communicatively coupled to the processor 1127. The memory1140 stores one or more files of compressed audio data. In someembodiments, the compressed audio data file 1142 is compressed using alossy compression algorithm, such as the MPEG-1 Audio Layer 3 (MP3)format for example. In some embodiments, the compressed audio data file1142 is compressed using a lossless compression algorithm. The seconddevice 1110 also includes a communication port 1130 and an audio port1160. The communication port 1130 may be a wired port or a wirelesscommunication port. In some embodiments, the second device 1110 is anadd-on module that may be attached by any of the methods described orincorporated herein. In some embodiments, the second device 1110includes a housing that includes a belt clip for wearing the seconddevice 1110 with a belt. In certain embodiments, the communication portsare IR ports and the belt positions the second device 1110 for IRcommunication. The audio port 1160 may communicatively coupled to aspeaker or to an audio jack, such as to receive an audio headphoneconnection for example.

The controller 1125 of the first device 1105 transmits a command to thesecond device 1110 to cause the second device 1110 to play thecompressed audio data file 1142. In some examples, the command iscommunicated using an open standard wireless communication protocol. Theprocessor 1127 of the second device 1110 receives the command and playsthe compressed audio data file 1142 via the audio port 1160 inaccordance with the command.

In some embodiments, the compressed audio file 1142 communicates analert concerning the first device 1105 when played. In certainembodiments, the compressed audio file 1142 communicates an occlusionalarm when blockage tubing of the first device 1105 is detected. Incertain embodiments, the compressed audio file 1142 communicates astatus of the second device when played. Examples of status alertsinclude, among other things, that the device is currently running atest, details of insulin therapy provided by the device, and any insulinpump problems. Communicating audible alerts is useful to assist a sightimpaired user of an insulin pump device.

In some embodiments, the compressed audio file 1142 communicates aresult of a test run using the first device 1105. In certainembodiments, the controller 1125 may be configured to run a test tocheck operation of the pump 1115. In certain embodiments, the controller1125 of the first device 1105 may be configured to calculate acarbohydrate ratio, to run a correction factor test, or to run a basalrate test.

As noted previously, a carbohydrate ratio refers to the amount ofcarbohydrates covered by a unit of insulin. Descriptions of devices andmethods that perform a carbohydrate ratio test are found in Blomquist,“Carbohydrate Ratio Testing Using Frequent Blood Glucose Input,” U.S.patent application Ser. No. 11/679,712, filed Feb. 27, 2007, which isincorporated herein by reference in its entirety. A correction factorrefers to the amount in drop in blood sugar, or blood glucose, for oneunit of insulin. Descriptions of devices and methods that perform acorrection factor test are found in Blomquist et al., “Correction FactorTesting Using Frequent Blood Glucose Input,” U.S. patent applicationSer. No. 11/626,653, filed Jan. 24, 2007, which is incorporated hereinby reference in its entirety. A basal rate test determines if a changeshould be made to a basal rate pattern. Descriptions of devices andmethods that perform a basal rate test are found in Blomquist et al.,“Basal Rate Testing Using Frequent Blood Glucose Input,” U.S. patentapplication Ser. No. 11/685,617, filed Mar. 13, 2007, which isincorporated herein by reference in its entirety. After running such atest, the controller 1125 transmits a command to the second device 1110to cause the second device 1110 to play a compressed audio data file1142 regarding the test.

In some embodiments, the memory 1140 stores a plurality of compressedaudio data files 1142 and the command indicates which audio data file toplay. In some embodiments, the first device 1105 communicates a file ofcompressed audio data to the second device via the communication ports1120, 1130. The second device 1110 then plays the communicated audiodata file.

In some embodiments, the first device 1105 includes a user interface1135 which includes a display 1145. The controller 1125 displays a menucontaining a plurality of audio files (e.g., songs) playable on thesecond device 1110. The controller 1125 receives an audio file selectionvia the user interface 1135 and communicates a selected audio fileoption to the second device 1110 which plays the correspondingcompressed audio data file 1142.

Temperature Monitoring

Stability of insulin is impacted by temperature. Insulin may become badif exposed to extremes of heat or cold. FIG. 12 is a flow diagram of anembodiment of a method 1200 to help an insulin pump user make best useof their pump. At block 1205, temperature is monitored using a devicethat includes an insulin pump. At block 1210, it is determined that acartridge of insulin has been installed in the device. At block 1215, atemperature that exceeds a first temperature threshold value is detectedwhile the insulin cartridge is installed. At block 1220, a warning isdisplayed when the temperature exceeds the first temperature thresholdvalue.

FIG. 13 is a block diagram of portions of a device 1300 to monitortemperature of insulin. The device 1300 includes a pump 1315 configuredto deliver insulin and a detection circuit 1365 configured to detectwhen a cartridge of insulin is installed in the device 1300. In someembodiments, the detection circuit 1365 includes a switch (e.g., abutton) that is activated when an insulin cartridge is inserted in thedevice 1300. The device 1300 also includes a temperature sensor 1350that produces an electrical temperature signal representative oftemperature, a display 1345, and a controller 1325. The controller 1325is communicatively coupled to the pump 1315, the detection circuit 1365,and the temperature sensor 1350.

The controller 1325 includes a comparison module 1330 to detect when thetemperature exceeds a first temperature threshold value while an insulincartridge is installed. The controller 1325 displays a warning when thetemperature exceeds the first temperature threshold value. In certainembodiments, the controller 1325 displays a warning that the insulin hasbeen exposed to a high temperature, or displays a recommendation thatthe user initiate more frequent blood glucose readings. In someexamples, the comparison module 1330 detects that the temperature isless than a second lower temperature threshold value while an insulincartridge is installed. The controller 1325 then displays a warning thatinsulin has been exposed to a low temperature.

According to some embodiments, the temperature sensor 1350 monitors thetemperature of the insulin cartridge. For example, the temperaturesensor 1350 may be located proximate to or in contact with the insulincartridge. The comparison module 1330 detects whether the temperature isbelow a second lower temperature threshold value. When the comparisonmodule 1330 indicates that the temperature is below the second lowertemperature threshold value, the controller 1325 displays a warning tocheck the insulin cartridge. In some embodiments, the comparison module1330 detects when the temperature of the insulin cartridge rises from atemperature below the second temperature threshold to a temperatureabove the first temperature threshold. The controller 1325 then displaysa recommendation that the user check for bubbles in the insulincartridge.

Measuring a time-temperature product may provide a better indication ofwhether the insulin has been affected by temperature. According to someexamples, the device 1300 includes a timer circuit 1370. The comparisonmodule 1330 measures the temperature using the temperature signal fromthe temperature sensor 1350, and measures a duration of time that themeasured temperature exceeds a threshold temperature value. Thecomparison module 1330 then determines a product of the measured timeduration and the measured temperature, and detects when the product ofthe measured time duration and temperature exceed a threshold productvalue. If the product of measured time and temperature exceeds thethreshold product value, the controller 1325 displays a warning, such asto check the insulin cartridge for bubbles or a warning that thetime-temperature rating has been exceeded, for example.

Food Scale Interface

A meal bolus is an amount of insulin delivered in anticipation of, or inresponse to, eating a meal. Typically, the meal bolus insulin is tocounteract or cover the amount the amount of carbohydrates in the meal.The proper amount of insulin can be influenced by many factors such asthe nutrient content of the food in the meal. Nutrient content refers tothe amount of carbohydrates, fiber, protein, and fat in the meal.Nutrient content may also include further indicate an amount offast-absorbing carbohydrates in the meal. Determining an appropriateamount of insulin in the meal bolus can be difficult for a pump user dueto difficulty in estimating the nutrient content of the food.

A food database contains the nutrient content for various types of food.The food database may include one or more food entries. A food databaseentry may include the nutrient content for a particular food (e.g.,apple), and the database entries can be combined to determine thenutrient content of a meal (e.g., chicken, potato, green beans). Anelectronic food scale is helpful in determining the nutrient content ofthe meal. For example, the protein content of chicken per gram stored inthe food database can be multiplied by the number of grams of chickendetermined by the food scale. Estimating the amount of nutrient contentin food would be easier for the insulin pump user if an electronic foodscale communicated food information with an insulin pump. In someembodiments, the food data base is stored in the insulin pump and theinsulin pump receives food weight information from the food scale. Insome embodiments, the food database is stored in the food scale and theinsulin pump receives food nutrient information from the food scale.

FIG. 14 is a flow diagram of an embodiment of a method 1400 ofautomatically determining an amount of insulin to deliver in a bolus inresponse to a pump user ingesting a meal (e.g., a meal bolus). At block1405, a database of food options is stored in association with a knownnutrient content in a memory of a device that includes an insulin pump.In some embodiments, a food database entry represents a food or acombination of foods. A food database entry may be stored as a recordincluding the food name and the nutrient content of the food whichincludes at least one of the amounts of carbohydrates, fiber, protein,and fat in the food. The food database entries may be combined todetermine the nutrient content for a meal. The food database entries maybe programmed into the insulin pump device by the user or a diabetesprofessional, or the food entries may be downloaded into the insulinpump device from a separate device.

At block 1410, a food selection of a user is received into the insulinpump device, such as via a user interface for example. In someembodiments, selecting a food option includes scrolling through a listof food options which may be displayed using text or using a graphic ofthe food. At block 1415, receiving a weight of the food selected isreceived into the insulin pump device from a second device. In someembodiments, the second device includes a food scale.

At block 1420, the insulin pump device calculates an amount of nutrientcontent in the food selection using the received weight. At block 1425,an amount of insulin to deliver is determined using the calculatedamount of nutrient content.

FIG. 15 is a block diagram of an embodiment of a device 1500 toautomatically determine an amount of insulin in an insulin bolus usingfood nutrient information. The device 1500 includes a pump 1515configured to deliver insulin and a memory 1540 to store a food database1542. In the food database 1542, food options are stored in associationwith a known amount of nutrient content. The device 1500 also includes auser interface 1535 configured to receive a food selection from a user,a communication port 1520, and a controller 1525. The communication 1520may be a wired port or a wireless port.

The controller 1525 is communicatively coupled to the pump 1515, thememory 1540, the user interface 1535, and the communication port 1520.The controller 1525 receives, via the communication port 1520, a weightof the food selected into the insulin pump device from a second device(e.g., an electronic food scale). If the communication port 1520 is awired port, the wired connection may be removable when not communicatinginformation. The controller 1525 includes a nutrient calculation module1532 that calculates an amount of nutrient content in the food selectionusing the received weight. For example, the food database 1542 mayinclude the amount of at least one of carbohydrates, fiber, protein, orfat per gram of the food. The nutrient calculation module 1532 thenmultiplies the nutrient information by the received weight to determinethe nutrient content of the meal.

The controller 1525 also includes an insulin calculation module 1530.The insulin calculation module 1530 determines an amount of insulin todeliver using the calculated amount. In some embodiments, the insulincalculation module 1530 uses at least one of a carbohydrate ratio,protein ratio, fat ratio, or fiber content to determine the amount ofinsulin to deliver. A carbohydrate ratio is sometimes referred to as acarbohydrate (or carb) factor and refers to the amount of carbohydratescovered by a unit of insulin. The insulin calculation module 1530 mayuse the carbohydrate ratio to automatically determine an amount ofinsulin required to match a number of carbohydrates ingested by thepatient, or at least an amount required to keep post-meal blood glucosewithin a range that is healthy for a patient. For example, the nutrientinformation may indicate that the food the pump user plans to eatincludes 70 grams of carbohydrates. If the carbohydrate ratio is 10grams of carbohydrates per unit of insulin (10 g/u), the insulin pumpdetermines that 7 units of insulin are required to cover thecarbohydrates. Because fiber is considered a carbohydrate but notmetabolized as a carbohydrate, the grams of fiber may be subtracted fromthe total grams of carbohydrates. Similar to a carbohydrate ratio, theinsulin calculation module 1530 may use a protein ratio to determine anamount of insulin required to cover the protein in the meal, and/or afat ratio to determine an amount of insulin required to cover the fat inthe meal.

In some embodiments, the insulin is delivered as a meal bolus. In someembodiments, the insulin calculation module 1530 determines a change toa type of meal bolus using the calculated amount of nutrient content.For example, the nutrient content may indicate an amount of fastabsorbing carbohydrates and an amount of slow absorbing carbohydrates.Based on the presence of fast and slow absorbing carbohydrates, theinsulin calculation module 1530 may determine to deliver the insulin tocover the meal in a combination bolus.

FIG. 16 illustrates a graph 1600 of an example of a combination bolus ofinsulin. The graph 1600 shows an amount of insulin delivered versustime. The combination meal bolus includes a first portion 1605 ofinsulin that is delivered immediately beginning at time t₀. The amountof insulin in the first portion 1605 may be determined using the amountof fast absorbing carbohydrates. The first portion 1605 concludes attime t₁ when a second portion 1610 of insulin begins to be delivered.The second portion 1610 is delivered over an extended period of timeuntil time t₂. The extended portion is delivered at a lower rate and fora longer period of time than the first portion 1605. The amount ofinsulin in the second portion 1610 may be determined using the amount ofslow absorbing carbohydrates.

FIG. 17 is a flow diagram of another embodiment of a method 1700 ofautomatically determining an amount of insulin to deliver in a bolus. Atblock 1705, a database of food options is stored in association with aknown nutrient content in a memory of a first device that includes aweight scale (e.g., an electronic food weight scale). At block 1710, afood selection of a user of a second device is received into the firstdevice. The second device includes the insulin pump.

At block 1715, food information is transmitted to the insulin pumpdevice using the weight scale device. The food information includes anamount of nutrient content of the food. At block 1720, an amount ofinsulin to deliver by the insulin pump device is determined using thefood information.

FIG. 18 is a block diagram of another example of a device 1800 toautomatically determine an amount of insulin in an insulin bolus usingfood nutrient information. The device 1800 includes a pump 1815configured to deliver insulin, a communication port 1820, and acontroller 1825. The controller 1825 receives information regarding thenutrient content of food via the communication port 1820. The nutrientcontent is of food to be eaten by the pump user and the information istransmitted by a second device, such as a device that includes a weightscale for example. In certain embodiments, the communication port 1820may be a wired port and the user connects the port when the informationis to be communicated. In certain embodiments, the communication port1820 is a wireless communication port.

The controller 1825 includes an insulin calculation module 1830 thatdetermines an amount of insulin to deliver, in anticipation of the usereating the meal, using the nutrient content information received intothe device 1800. In some embodiments, the insulin is delivered as a mealbolus. In some embodiments, the insulin calculation module determines,using the nutrient content, whether the meal bolus should include anextended bolus. In certain examples, the extended bolus is included in acombination bolus, such as the illustrative example shown in FIG. 16.The second portion 1610 of the combination bolus is an extended bolus.

Personal Information Manager Feature

Information related to the daily routine of an insulin pump user isoften in electronic form. For example, the user may have a personalinformation manager (PIM) device, such as a personal data assistant(PDA) or the like. Information related to daily events of the user isstored in the device using an interactive calendar. This information mayuseful in setting or adjusting insulin therapy from an insulin pump.

FIG. 19 shows a flow diagram of an embodiment of a method 1900 toprogram an insulin pump device using an interactive calendar. At block1905, information is communicated between a first device that includesan insulin pump and a second device that includes an interactivecalendar. In some embodiments, the second device is an add-on module tothe insulin pump device. In some embodiments, the second device is aseparate device (e.g., a PDA or any computing device running aninteractive calendar program). The information communicated between thetwo devices includes a calendar event of a user of the first deviceentered into the interactive calendar of the second device.

At block 1910, operation of the first device is altered according to thecommunicated calendar event. Examples of altering operation if the firstdevice include, among other things, changing a delivery of insulin,activating an exercise basal rate pattern, and changing an alarm mode ofthe first device.

FIG. 20 is a block diagram of portions of a system 2000 that includes aninsulin pump device. The system 2000 includes a first device 2005 and asecond device 2010. The first device 2005 is an insulin pump device andincludes the pump 2015, a first communication port 2020, and acontroller 2025 that initiates insulin therapy delivered by the pump2015.

The second device 2010 implements an interactive calendar and includes amemory 2040 to store a plurality of calendar events of a user, a userinterface 2035 including a display 2045, a second communication port2030, and a processor 2027. The user interface 2035 receives a calendarevent into the memory 2040 of the second device 2010 and the processor2027 displays the calendar event. The processor 2027 is configured tocommunicate information to the first device 2005 using the secondcommunication port 2030. The communicated information includes acalendar event of the user. The controller 2025 of the first device 2005alters operation of the first device according to the communicatedcalendar event.

According to some embodiments, the communicated calendar event includesa meal time of the user. The controller 2025 schedules a missed mealbolus alarm in a time relation to the meal time (e.g., a specified timeduration after the scheduled meal time). If the user fails to initiate ameal bolus using the first device 2005, the controller 2025 generates amissed meal bolus alarm, or other kind of alert to the user. The usermay then initiate the meal bolus if they did indeed eat and forgot toinitiate a meal bolus, or may merely cancel the alarm if they did noteat at the scheduled time.

According to some embodiments, the communicated calendar event includesan exercise time. In some embodiments, the exercise time is when theuser exercises according to a specified exercise regimen (e.g., walkinga specified distance). The controller 2025 of the insulin pump devicechanges a delivery of insulin in relation to the communicated exercisetime. For example, the controller 2025 may automatically change thebasal rate pattern delivered by the device to an exercise basal ratepattern or profile that corresponds to the specified exercise. Thecontroller 2025 changes to the exercise basal pattern in relation to thecommunicated exercise time (e.g., a specified time duration before theexercise regimen begins, as the regimen is scheduled to begin, or a timeduration after the exercise regimen begins). In some examples, the firstdevice 2005 includes a display and displays a prompt as to whether theuser wishes to activate the exercise basal rate pattern. The user maythen enable or cancel activation of the exercise basal rate pattern.

In some embodiments, the controller 2025 calculates an amount ofcarbohydrates metabolized by the specified exercise regimen and reducesan amount of insulin to be delivered by the first device 2005 by anamount that covers the metabolized carbohydrates. Examples of devicesthat calculate carbohydrates metabolized by exercise were describedpreviously in regard to FIG. 7.

The first device 2005 may include an audible indicator 2070 and avibration mechanism 2075 communicatively coupled to the controller 2025.An example of an audible indicator 2070 is a transducer or speaker. Thecontroller 2025 may include an alarm module 2032 to generate an audiblealert, such as a reminder to initiate a meal bolus or a reminder to takea blood glucose measurement for example. The alarm module 2032 generatesa vibratory alert for such reminders using the vibration mechanism 2075.In some embodiments, the communicated calendar event includes a meetingtime and, according to the meeting time, the alarm module 2032 switchesan alarm mode of the first device 2005 between an audible mode and avibratory mode according to the communicated meeting time. Thus, thealarm module 2032 automatically switches from the audible alert to asilent alert during the meeting time, and may switch back from thesilent alert to the audible alert after the meeting time.

According to some examples, the first device 2005 includes a memory 2042coupled to or integral to the controller 2025. The memory 2042 includesan insulin therapy event log memory area 2044. The controller 2025stores an event related to insulin therapy in association with thecommunicated calendar event as a log entry in the insulin therapy eventlog memory area 2044. Storing an insulin therapy event in associationwith the communicated calendar event is useful to provide context toinsulin therapy events such as blood glucose readings or pump deliveriesof insulin. In some examples, the controller 2025 generates a reportthat includes one or more log entries from the insulin therapy event logmemory area 2044. The report may be displayed via a display included inthe first device 2005, or the report may be communicated via thecommunication port to the second device 2010 or a third device fordisplay or printing. The generated report may be useful in makingdecisions concerning adjustment to insulin therapy provided by theinsulin pump device.

Speech Recognition

In some situations it may be desirable to communicate with an insulinpump device without the need to navigate operational menus displayed onthe insulin pump device. For example, the pump user may be visuallyimpaired. For this reason, it is desirable to provide speech recognitioncapability in an insulin pump device.

FIG. 21 is a flow diagram of an embodiment of a method 2100 of operatingan insulin pump device. At block 2105, acoustic energy is received intoa device that includes an insulin pump. Typically, the acoustic energyis radiated from speech of the insulin pump user. At block 2110, anelectrical audio signal is generated by the insulin pump device usingthe received acoustic energy. At block 2115, a command is derived fromthe electrical audio signal. At block 2135, altering operation of theinsulin pump device is altered according to the derived command. Forexample, the command may be, among other things, a command to initiateor change a delivery of insulin from the insulin pump device, to run adevice test, or to change an operating parameter of the device.

FIG. 22 is a block diagram of portions of a device 2200 to provide voicecontrol of insulin therapy. The device 2200 includes a pump 2215configured to deliver insulin, an acoustic transducer 2250, a speechrecognition circuit 2280, and a controller 2225. The acoustic transducer2250 receives acoustic energy and generates an electrical transducersignal representative of the acoustic energy. An example of an acoustictransducer is a microphone. The acoustic energy is typically generatedfrom speech of the pump user or another person interacting with thedevice 2200. The device may include a transducer interface circuit suchas a sampling circuit 2252 that produces digitized samples of theelectrical transducer signal. The speech recognition circuit 2280derives a command from the digitized samples. In some embodiments, thespeech recognition circuit 2280 includes digital signal processingcircuitry to derive the command. In some embodiments, the acoustictransducer 2250, the transducer interface circuit, and the speechrecognition circuit 2280 are included in an add-on module. The add-onmodule may include a second processor, such as a digital signalprocessor (DSP), coupled to the speech recognition circuit 2280 toderive the command and a communication port to communicate a derivedcommand to the controller 2225.

The controller 2225 alters operation of the device 2200 according to thederived command. In some embodiments, the command derived by the speechrecognition circuit 2280 from the electrical transducer signal is toinitiate delivery of a correction bolus of insulin. In some embodiments,the command derived by the speech recognition circuit 2280 from theelectrical transducer signal is to initiate delivery of a meal bolus ofinsulin. The controller 2225 then initiates delivery of the correctionbolus or meal bolus according to the derived command.

In some embodiments, the command derived by the speech recognitioncircuit 2280 is to change a basal insulin rate pattern or basal rateprofile. In certain embodiments, the device 2200 may include a memory2240 that stores a plurality of basal rate patterns. The derived commandmay be to activate a different basal rate pattern than the basal ratepattern that is currently active. For example, the memory 2240 may storedifferent basal rate patterns for different activity levels of the pumpuser. The pump user may speak a command to activate an exercise basalrate pattern, and the speech recognition circuit 2280 derives the user'scommand. In some embodiments, the speech recognition circuit 2280derives a command to deactivate insulin pump therapy and controller 2225deactivates the therapy provided by the pump when the command isderived. This deactivation may be implemented as an emergency shut-offcommand.

According to some embodiments, the controller 2225 runs one or moredevice-based tests. The speech recognition circuit 2280 is configured toderive a command to run a device test, and the controller 2225 isconfigured to initiate the test according to the command. In certainembodiments, the controller 2225 is configured to execute a devicediagnostic test. In certain embodiments, the controller 2225 isconfigured to execute a carbohydrate ratio test. Descriptions of devicesand methods that perform a carbohydrate ratio test are found in thepreviously mentioned U.S. patent application Ser. No. 11/679,712. Incertain embodiments, the controller 2225 is configured to execute acorrection factor test. Descriptions of devices and methods that performa correction factor test are found in the previously mentioned U.S.patent application Ser. No. 11/626,653. In certain embodiments, thecontroller 2225 is configured to execute a basal rate test. Descriptionsof devices and methods that perform a basal rate test are found in thepreviously mentioned U.S. patent application Ser. No. 11/685,617. Thecontroller 2225 runs the carbohydrate ratio test, the correction factortest, or the basal rate test according to the derived command.

According to some embodiments, at least one operating parameter 2244 ofthe device 2200 is stored in the memory 2240. The speech recognitioncircuit 2280 derives a command from the transducer signal to change theoperating parameter 2244 of the device 2200. The controller 2225 updatesthe operating parameter 2244 in the memory 2240 in response to thederived command. In certain embodiments, the operating parameter is acorrection factor. The pump user speaks a command to update thecorrection factor to a specified value. The speech recognition circuit2280 derives the command to change the correction factor and derives thespecified value of the correction factor from the transducer signal. Thecontroller 2225 updates the correction factor in memory 2240.

In certain embodiments, the operating parameter is a carbohydrate ratio.The pump user speaks a command to update the carbohydrate ratio to aspecified value. The speech recognition circuit 2280 derives the commandto change the carbohydrate ratio and derives the specified value ofcarbohydrate ratio from the transducer signal. The controller 2225updates the carbohydrate ratio in memory 2240.

It may be desirable to enable operation of the device 2200 with speechrecognition only during certain times. This may help avoid inadvertentchanges to operation of the device 2200. In some embodiments, the speechrecognition feature must be enabled on the device 2200 before use. Thedevice 2200 includes a user interface 2235 communicatively coupled tothe controller 2225. The controller 2225 deactivates processing of audiosignals until an activation signal is received via the user interface2235. The processing of audio signals continues until a deactivationsignal is received via the user interface 2235.

Ambient noise may make it difficult for the speech recognition featureto derive commands from speech. In some embodiments, the device 2200includes a vibration mechanism 2075 communicatively coupled to thecontroller 2225. The speech recognition circuit 2280 generates anindication when ambient noise prevents speech recognition from thedigitized samples. For example, the speech recognition circuit 2280 maydetect that ambient noise is above a threshold ambient noise level. Whenthe controller 2225 receives such an indication from the speechrecognition circuit, the controller 2225 provides a vibratory alertusing the vibratory mechanism. Thus, the device 2200 alerts the userwhen speech recognition may not be usable.

It may be desirable to add a measure of security in using the speechrecognition feature. In some embodiments, operation of the device 2200by speech recognition is enabled by a specified password. The speechrecognition circuit 2280 derives a message corresponding to a spokenpassword from the digitized samples from the sampling circuit 2252. Thecontroller 2225 deactivates altering operation of the device accordingto a derived command until the message with the password is derived.Thus, speech recognition is active, but commands to alter operation ofthe device are not derived until the password is detected.

In some embodiments, operation of the device 2200 by speech recognitionis only allowed when the device 2200 verifies the speaker is the insulinpump user. This is referred to as voice recognition or speakerverification. In some embodiments, the device 2200 includes a speakerverification circuit 2285 communicatively coupled to the samplingcircuit 2252 and the controller 2225. The speak verification circuit isconfigured to verify that the digitized samples from the samplingcircuit 2252 correlate to a pump user's voice. The controller altersoperation of the device 2200 using the derived command from the speechrecognition circuit 2280 only when the speaker verification circuit 2285also verifies that the command came from the user's voice. In certainembodiments, the speaker verification circuit 2285 includes a DSP. Incertain embodiments, the speaker verification circuit 2285 executesadaptive learning to recognize the pump user's voice.

According to some embodiments, voice operation of the insulin pumpdevice includes outputting recorded voice prompts to the insulin pumpuser. In some embodiments, the memory 2240 stores one or more files ofcompressed audio data. The device 2200 includes an audio port 2260communicatively coupled to the controller 2225. The audio port 2260 maybe coupled to a speaker or to an audio jack to receive headphones. Thecontroller 2225 plays the compressed audio data file via the audio port2260. For example, the controller 2225 may play a compressed audio datafile to ask the user whether they want to initiate a meal bolus. Thismay be played as part of a meal bolus reminder. The controller initiatesthe meal bolus when the speech recognition circuit 2280 derives the word“yes” from the user, and does not initiate the meal bolus if the speechrecognition circuit 2280 derives the word “no” from the user. Othercompressed data files may be played to provide alarms or alerts to theuser, to inquire whether the user wants to run a device test, or toprovide an acknowledge message to the pump user that a command from theuser was derived and executed.

Kinetic Battery

Insulin pumps are typically battery powered devices. It may desirable toextend the battery life of an insulin pump device. FIG. 23 is blockdiagram of portions of an embodiment of a device 2300 to provide insulintherapy. The device 2300 includes a pump 2315 configured to deliverinsulin and a controller 2325 to initiate delivery of insulin therapyfrom the pump 2315. The device 2300 also includes a primary batterycircuit 2390 and a kinetic battery circuit 2392. The primary batterycircuit 2390 provides energy to the device 2300 from a primary battery2388. The kinetic battery circuit 2392 provides energy to at least aportion of the device 2300 from a kinetic battery 2391. The kineticbattery circuit 2392 also converts motion of a user to charge stored ina kinetic battery 2391, such as by using moving magnets to createelectrical energy in coils of wire.

The device 2300 further includes a comparison circuit 2394 and aswitching circuit 2396. The switching circuit 2396 switches the powersource of at least of a portion of the device 2300 between the primarybattery circuit 2390 and the kinetic battery circuit 2392. Thecomparison circuit 2394 compares a charge on the kinetic battery 2391 toa threshold charge value. When the comparison circuit 2394 detects thatthe charge on the kinetic battery 2391 exceeds the threshold, theswitching circuit 2396 provides energy from the kinetic battery circuit2392 to at least a portion of the device 2300. When the charge on thekinetic battery 2391 is less than the threshold, the switching circuit2396 provides energy to the portion from the primary battery circuit2390. In some embodiments, the kinetic battery circuit 2392 and kineticbattery 2391 are included in an add-on module that is connected to theswitching circuit 2396.

According to some examples, because the kinetic battery circuit 2392converts movement of the pump user into battery energy, the kineticbattery circuit 2392 can be used to detect user activity. In someembodiments, the device 2300 includes a charge measurement circuit 2398communicatively coupled to the kinetic battery circuit and thecontroller, which is configured to measure a level of charge on thekinetic battery 2391. The controller 2325 includes an activity detectionmodule 2360 configured to determine an activity level of the user fromthe measured level of charge. For example, the activity detection module2360 may store a first value Q₁ representing a level of charge on thekinetic battery at time t₁. At a later time, t₂, the activity detectionmodule 2360 may determine that the charge on the kinetic battery hasincreased to a second value Q₂ during the time period from time t₁ tot₂. The activity detection module 2360 may detect that the activitylevel of the user is increasing from the increase in charge.

In some embodiments, the activity detection module 2360 may determinethe activity level of the user from the difference between the firstvalue of charge and the second value of charge (e.g., Q₂−Q₁). In certainembodiments, the charge measurement circuit 2398 is configured tomeasure a rate of change of the charge on the kinetic battery 2391. Theactivity detection module 2360 determines the activity level of the userusing the measured rate of change of the charge.

For example, the activity detection module 2360 may determine the rateof change by dividing the difference in charge values by the differencein time, or

$\frac{Q_{2} - Q_{1}}{t_{2} - t_{1}}.$

Larger values for the rate of change indicate a higher activity level ofthe pump user.

In some embodiments, the controller 2325 includes an insulin calculationmodule 2330 that calculates a change in a delivery of insulin accordingto the indicated activity level. The calculated change to insulintherapy may include a calculated reduction in an amount of insulin in atleast one of a correction bolus, a meal bolus, or a basal insulin ratepattern according to the activity level. As discussed previously inregard to FIGS. 6 and 7, the insulin calculation module 2330 uses theactivity level to calculate an amount of carbohydrates metabolized bythe exercise, such as by using a conversion rule for example. Theinsulin calculation module 2330 then calculates a reduction of an amountof insulin by an amount that covers the metabolized amount ofcarbohydrates.

In some embodiments, the device 2300 includes a memory 2340 that may beintegral to the controller 2325 or communicatively coupled to thecontroller 2325. The memory 2340 stores an exercise basal rate pattern.The controller 2325 activates the exercise basal rate pattern accordingto the indicated activity level.

The kinetic battery circuit 2392 may be used to provide energy to theentire device 2300 or to portions of the device 2300. In someembodiments, the device 2300 includes a blood glucose sensor circuit2355 to produce an electrical blood glucose signal representative of ablood glucose level of the patient. The switching circuit 2396 providesenergy to the blood glucose sensor circuit 2355 from the kinetic battery2391 when the charge on the kinetic battery 2391 exceeds the thresholdcharge value. In some embodiments, the device 2300 includes atemperature sensing circuit 2350 that produces an electrical temperaturesignal representative of temperature. The switching circuit 2396provides energy to the temperature sensing circuit 2350 from the kineticbattery 2391 when the charge on the kinetic battery 2391 exceeds thethreshold charge value. In some embodiments, the device 2300 includes adisplay 2345. The switching circuit 2396 provides energy to the display2345 from the kinetic battery 2391 when the charge on the kineticbattery 2391 exceeds the threshold charge value.

FIG. 24 is a flow diagram of an embodiment of a method 2400 of extendingthe primary battery life of an insulin pump. At block 2405, motion of auser of a device that includes an insulin pump is used to charge akinetic battery of the insulin pump device. At block 2410, energy isprovided to a circuit of the insulin pump device from the kineticbattery when the charge on the kinetic battery exceeds a thresholdcharge value. At block 2415, energy is provided to the circuit of theinsulin pump from the primary battery when the charge on the kineticbattery is less than the threshold charge value.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments in which theinvention can be practiced. These embodiments are also referred toherein as “examples.” All publications, patents, and patent documentsreferred to in this document are incorporated by reference herein intheir entirety, as though individually incorporated by reference. In theevent of inconsistent usages between this document and those documentsso incorporated by reference, the usage in the incorporated reference(s)should be considered supplementary to that of this document; forirreconcilable inconsistencies, the usage in this document controls.

It is to be understood that the above description is intended to beillustrative, and not restrictive. For example, the above-describedembodiments (and/or aspects thereof) may be used in combination witheach other. Many other embodiments will be apparent to those of skill inthe art upon reviewing the above description. The scope of the inventionshould, therefore, be determined with reference to the appended claims,along with the full scope of equivalents to which such claims areentitled. In the appended claims, the terms “including” and “in which”are used as the plain-English equivalents of the respective terms“comprising” and “wherein.”Also, in the following claims, the terms“including” and “comprising” are open-ended, that is, a system, device,article, or process that includes elements in addition to those listedafter such a term in a claim are still deemed to fall within the scopeof that claim. Moreover, in the following claims, the terms “first,”“second,” and “third,” etc. are used merely as labels, and are notintended to impose numerical requirements on their objects. In thisdocument, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one. In this document, the term“or” is used to refer to a nonexclusive or, such that “A or B” includes“A but not B,” “B but not A,” and “A and B,” unless otherwise indicated.

The Abstract is provided to comply with 37 C.F.R. §1.72(b), to allow thereader to quickly ascertain the nature of the technical disclosure. Itis submitted with the understanding that it will not be used tointerpret or limit the scope or meaning of the claims. Also, in theabove Detailed Description, various features may be grouped together tostreamline the disclosure. This should not be interpreted as intendingthat an unclaimed disclosed feature is essential to any claim. Rather,inventive subject matter may lie in less than all features of aparticular disclosed embodiment. Thus, the following claims are herebyincorporated into the Detailed Description, with each claim standing onits own as a separate embodiment. The scope of the invention should bedetermined with reference to the appended claims, along with the fullscope of equivalents to which such claims are entitled.

1-26. (canceled)
 27. An ambulatory infusion pump, comprising: a pumpconfigured to deliver a fluid to a user; a communications port; and acontroller communicatively coupled to the pump and the communicationsport and configured to: receive via the communications port from aseparate device a calendar event stored on an interactive calendar ofthe separate device, the calendar event relating to an activity of theuser of the infusion pump; and alter operation of the infusion pumpbased on the calendar event.
 28. The ambulatory infusion pump of claim27, wherein altering operation of the infusion pump includes changingdelivery of fluid.
 29. The ambulatory infusion pump of claim 28, whereinthe calendar event includes an exercise time, and changing delivery offluid includes switching from a current basal rate pattern to anexercise basal rate pattern that corresponds to the exercise time. 30.The ambulatory infusion pump of claim 29, wherein the exercise basalrate pattern corresponds to a specified exercise regimen.
 31. Theambulatory infusion pump of claim 27, further comprising a display, andwherein the controller is further configured to display a prompt on thedisplay as to whether to alter operation based on the calendar event.32. The ambulatory infusion pump of claim 27, wherein the calendar eventincludes an a meal time of the user, and wherein altering operation ofthe ambulatory infusion pump includes scheduling an alert if the userfails to initiate a meal bolus within a specified time of the expectedmeal time.
 33. The ambulatory infusion pump of claim 27, wherein thecalendar event includes a meeting time, and wherein altering operationof the ambulatory infusion pump includes switching an alarm mode foralarms issued by the controller from an audible mode.
 34. The ambulatoryinfusion pump of claim 33, wherein switching the alarm mode from anaudible mode includes switching the alarm mode to vibratory mode. 35.The ambulatory infusion pump of claim 26, wherein the separate devicefrom which the controller is configured to receive a calendar event is ahandheld computing device.
 36. The ambulatory infusion pump of claim 26,wherein the fluid is insulin.
 37. The ambulatory infusion pump of claim26, wherein the communications port is selected from the groupconsisting of a wireless communications port and a wired communicationsport.
 38. The ambulatory infusion pump of claim 37, whereincommunications port is a wireless communications port and the wirelesscommunications port is selected from the group consisting of a radiocommunications port and an infrared communications port.
 39. Anapparatus comprising: a pump configured to deliver a fluid to a user; acommunication port; and a controller communicatively coupled to the pumpand the communication port, wherein the controller is configured tocommunicate information, via the communication port, with a separatedevice that implements an interactive calendar, wherein the informationincludes a calendar event from the interactive calendar, and wherein thecontroller is further configured to alter operation of the apparatusaccording to the communicated information.
 40. The apparatus of claim38, wherein the calendar event includes a meal time, and wherein thecontroller is configured to alter operation of the apparatus by:scheduling a missed meal bolus alarm in a time relation to the mealtime; and generating the missed meal bolus alarm if the user fails toinitiate a meal bolus within a time specified by the missed meal bolusalarm.
 41. The apparatus of claim 38, wherein the communicated calendarevent includes an exercise time, and wherein the controller isconfigured to alter operation of the apparatus by changing a delivery offluid in relation to the exercise time.
 42. The apparatus of claim 41,wherein the controller is configured to: calculate an amount ofcarbohydrates metabolized by the exercise; and reduce an amount of fluidto be delivered by an amount that covers the metabolized carbohydrates.43. The apparatus of claim 41, wherein the controller is configured tochange delivery of fluid according to an exercise basal rate pattern inrelation to the exercise time.
 44. The apparatus of claim 39, includingan audible indicator and a vibration mechanism communicatively coupledto the controller, wherein the communicated calendar event includes ameeting time, and wherein the controller includes an alarm moduleconfigured alter operation of the apparatus by switching an alarm modeof the apparatus between an audible mode and a vibratory mode accordingto the communicated meeting time.
 45. An infusion pump, comprising: apump configured to deliver fluid to a user; a communications port; amemory; a controller communicatively coupled to the pump device, thecommunications port and the memory and configured to: establish aconnection with a separate device through the communications port;receive through the communications port from the separate device aplurality of calendar events of the user stored on an interactivecalendar on the separate device; and store the plurality of calendarevents in the memory.
 46. The infusion pump of claim 45, wherein thecontroller is configured to alter operation of the infusion pump basedon one or more of the calendar events.
 47. The infusion pump of claim46, wherein altering operation of the infusion pump based on one or moreof the calendar events includes at least one of changing a delivery offluid with the pump, activating an exercise fluid delivery pattern andchanging an alarm mode of the infusion pump.
 48. The ambulatory infusionpump of claim 45, wherein establishing a connection with a separatedevice includes establishing a connection with a handheld computingdevice.
 49. The ambulatory infusion pump of claim 45, wherein the fluidis insulin.